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Tag: opioids

Purdue Pharma and other pioneers of powerful opioid painkillers probably felt a twinge of regret on Friday when the FDA approved a powerful new opioid painkiller that’s 10 times stronger than fentanyl – the deadly synthetic opioid that’s been blamed for the record number of drug overdose deaths recorded in 2017 – and 1,000 times more powerful than morphine, ignoring the objections of lawmakers and its own advisory committee in the process.

After all that trouble that purveyors of opioids like Purdue and the Sackler family went to in order to win approval –doctoring internal research and suborning doctors to convince the FDA to approve powerful painkillers like OxyContin despite wildly underestimating the drug’s abuse potential – the agency might very well have approved those drugs any way? And opioid makers might have been able to avoid some of the legal consequences stemming from this dishonesty, like the avalanche of lawsuits brought by state AGs.

What’s perhaps even more galling is that the FDA approved the drug after official data showed 2017 was the deadliest year for overdose deaths in US history, with more than 70,000 recorded drug-related fatalities, many of which were caused by powerful synthetic opioids like the main ingredient in Dsuvia, the brand name under which the new painkiller will be sold.

Dsuvia is a 3-millimeter tablet of sufentanil made by AcelRx. It’s a sublingual tablet intended to provide effective pain relief in patients for whom most oral painkillers aren’t effective. The FDA’s advisory committee voted 10-3 to recommend approval of the drug, a decision that was accepted by the FDA on Friday. The agency justified its decision by insisting that Dsuvia would be subject to “very tight” restrictions.

“There are very tight restrictions being placed on the distribution and use of this product,” said FDA Commissioner Scott Gottlieb in a written statement Friday regarding his agency’s approval of Dsuvia. “We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia.”

Still, some of the agency’s actions looked to critics like attempts to stifle internal criticism. For example, the agency scheduled the advisory committee vote on a day where the chairman of the committee, who was opposed to approval, could not attend – while circumventing its normal vetting process, despite the fact that the member in question had notified the agency of his unavailability months beforehand.

But the FDA rejected any and all criticisms related to Dsuvia being sold as a street drug by insisting that the risk of diversion (when doctor-prescribed drugs are illicitly sold on the black market) was low because the drug would only be prescribed in hospital settings, and wouldn’t be doled out at pharmacies. But critics said that, given its potency, Dsuvia would “for sure” be diverted at some level. They also rejected the FDA’s argument that Dsuvia satisfied an important need for pain treatment: offering rapid, effective relief for obese patients or others lacking easily accessible veins.

While a niche may eventually be found for Dsuvia, “it’s not like we need it…and it’s for sure, at some level, going to be diverted,” said Dr. Palmer MacKie, assistant professor at the Indiana University School of Medicine and director of the Eskenazi Health Integrative Pain Program in Indianapolis. “Do we really want an opportunity to divert another medicine?”

Fortunately for Dsuvia’s manufacturer, AcelRx, these public health risks pale in comparison to the enormous profits that the company stands to reap from sales. The company anticipates $1.1 billion in annual sales, and hopes to have its product in hospitals early next year.

It goes without saying that cancer patients and others suffering from life threatening illnesses have a legitimate need for effective pain relief. But when the FDA says Dsuvia is needed in the hospital setting, it probably isn’t telling the whole story. Because, as the Washington Post pointed out, the medication’s development was financed in part by the Department of Defense, which believes Dsuvia will be an effective treatment for emergency pain relief on the battlefield – like when a soldier gets his legs blown off after accidentally stepping on an IUD.